Gastric accommodation [ Time Frame: Change in total volume consumed during the satiety test from baseline to end of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

secondary outcome measures will include improvement in symptom severity. [ Time Frame: Improvement in symtoms after 4 weeks of Kuvan 10mg/kg and 4 weeks of Kuvan 20 mg/kg. ] [ Designated as safety issue: No ]

secondary outcome measures will include improvement in quality of life. [ Time Frame: Improvement in quality of life after 4 weeks of Kuvan 10mg/kg and 4 weeks of Kuvan 20 mg/kg ] [ Designated as safety issue: No ]

Patients are invited to participate in a research study of Kuvan® (sapropterin dihydrochloride). We hope to learn whether treatment with Kuvan® is safe and effective in improving the ability of the stomach to relax after eating and improving the symptoms of diabetic gastroparesis. Women are selected as a possible participant in this study because they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:Inclusion Criteria

Patients with moderate to severe symptoms of diabetic gastroparesis will be studied (GCSI >21). Patients should not have post-surgical gastroparesis or dyspeptic symptoms with normal gastric emptying. In order to qualify for inclusion in the trial, patients must satisfy the following inclusion criteria:

Patients with uncontrolled diabetes, such as HbA1c > 10 mg/dl at screening/baseline will be excluded.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135186